Can Being Too Clean Cause Crohn's Disease?

Researchers at a tiny company by the name of Coronado Bioscience, based in Burlington, Massachusetts, say they have enough information to show that this is true and plan to be introducing a new and radically different product in the next few years to fight autoimmune diseases like Crohn's Disease, Rheumatoid Arthritis and even Multiple Sclerosis.

Studies have shown that the incidence of autoimmune disease tends to be highest in the developed world, and particularly the highest upper-income groups. Researchers hypothesize that the elimination of certain intestinal parasites may have led to the loss in some individuals of a key mechanism for modulating their immune systems.

The technology behind Coronado's new product was developed by Dr. Joel Weinstock, chief of gastroenterology and hepatology at Tufts Medical Center in Boston, and advisor to Coronado Bioscience, along with researchers at the University of Iowa. It is based on the "hygiene hypothesis," which holds that many developed countries have, in some ways, become too clean for their own good.

Today in many parts of the modern world organisms or parasites, are kept at bay with an array of antibacterial soaps, detergents and sanitizing gels. However in third world countries where few if any of these sanitation aids are present, millions of organisms, including viruses, bacteria and worms, freely enter the body through contact with dirt. However, Researchers believe many of these organisms are needed to train the body's immune system to recognize and fight disease. That is why the poorer countries have very few Crohn's Disease suffers.

Coronado Bioscience is developing what it hopes will be the first in a new class of treatments for autoimmune conditions. Each dose of the drug consists of thousands of microscopic parasite eggs, culled from pig feces, suspended in a tablespoon of saline solution to be swallowed.

In a pig, the eggs would grow into mature whipworms and reproduce, without harming their host. In humans, the same eggs barely survive two weeks. Yet in that short period they appear to modulate a patient's immune system and prevent it from attacking the body's own tissues and organs. Better yet, according to Coronado's chief executive officer, Bobby Sandage Jr., "With the pig whipworm, there is no permanent infection, no real possible side effects".

Coronado's partner, German drug maker Dr. Falk Pharma GmbH, is conducting a midstage trial of the drug, known as trichuris suis ova (TSO), in Europe. The two companies plan to share data when filing for marketing approval in 2016 or 2017

The company is also preparing to enroll 220 patients with Crohn's disease in a midstage clinical trial. Participants will receive either a dose with 7,500 eggs from a pig whipworm or a placebo once every two weeks for 12 weeks.

However, the big question remains: If you had a chronic and potentially debilitating condition such as rheumatoid arthritis or Crohn's disease, and swallowing the eggs of a pig parasite could help, would you do it?

The team at Coronado Biosciences Inc. is betting you would. Here are a few reasons why:

"It really does take a bit of getting used to. But once you talk to patients and they understand the theory, they accept it. We have had no trouble recruiting," said Dr. John Fleming, a professor of neurology at the University of Wisconsin who is testing the drug in patients with multiple sclerosis. Humans and their parasites have evolved in tandem for millennia. Most parasites have found ways to feed off humans without killing them, and some have become important for health.

Another reason that Crohn's and other autoimmune sufferers could be convinced to drink this stuff was offered by Coronado CEO Sandage saying, standard drug treatments for autoimmune disorders carry many risks to use "standard treatments for autoimmune disorders include injectable drugs that block a protein known as tumor necrosis factor. They include Amgen's Enbrel and Abbott's Humira. These depress the immune system and send its army of infection-fighting cells back to their barracks. They also raise the risk of serious infection, including tuberculosis, and some types of cancer". This is a big reason why patients with serious Crohn's conditions would choose the company's drug despite its radical departure from the normal medicines offered for years.